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Manager, Quality Operations at Amylyx Pharmaceuticals - ApplyBlast

Manager, Quality Operations

Amylyx Pharmaceuticals

3 months ago

3.8 on Glassdoor

Cambridge, MA, United States

Hybrid

Full Time

Manager

0 applicants

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About this role

The Manager, Quality Operations role at Amylyx provides CMC quality oversight for sterile drug product manufacturing, labeling, packaging, and distribution. This position ensures compliance with global GMP and GDP standards while reviewing validation documents, batch records, and regulatory submissions. The role involves leading internal and external meetings as a subject matter expert and supporting FDA or EMA inspections.

Responsibilities

Provide quality oversight of sterile drug product production activities
Review and approve validation documents and batch production records
Write and approve SOPs for manufacturing and packaging operations
Support FDA and EMA regulatory agency inspections
Lead meetings as a Quality SME for GMP and GDP compliance

Skills

Qualifications

Bachelor's degree in related fieldMaster's degree or PhD preferred3+ years in sterile manufacturing environment

About Amylyx Pharmaceuticals

amylyx.com

Headquarters

Cambridge, Massachusetts, United States

Company Size

201-500 employees

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Amylyx Pharmaceuticals is a biopharmaceutical company focused on developing novel therapies for diseases with high unmet needs, including Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Amyotrophic Lateral Sclerosis (ALS). Its lead program, Avexitide, is being evaluated in the pivotal Phase 3 LUCIDITY clinical trial for PBH. Amylyx advances its pipeline using rigorous science, well-defined mechanistic rationale, and a strong commitment to the patient communities it serves.